NCT00826137

Brief Summary

Prospective randomized double-blind study on the effect of prebiotics (inulin and fructo-oligosaccharides) in the prevention of antibiotic-associated diarrhea in children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2008

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

1 year

First QC Date

December 29, 2008

Last Update Submit

June 13, 2012

Conditions

Antibiotic-Associated Diarrhea

Keywords

prebioticsAntibiotic-associated diarrhea

Outcome Measures

Primary Outcomes (1)

  • Prevention of diarrhea.

    During antibiotic treatment+14 days

Secondary Outcomes (1)

  • Duration of diarrhea.

    During antibiotic treatment+14 days

Study Arms (2)

A

EXPERIMENTAL

Treated with prebiotics.

Dietary Supplement: Inulin and fructo-oligosaccharides.

B

PLACEBO COMPARATOR

Placebo treated.

Dietary Supplement: Placebo

Interventions

Inulin and fructo-oligosaccharides.DIETARY_SUPPLEMENT

Supplement during antibiotic treatment+14 days.

Also known as: Placebo is base powder of product with no oligosaccharides.
A
PlaceboDIETARY_SUPPLEMENT

Placebo is base powder of product with no oligosaccharides.

B

Eligibility Criteria

Age6 Months - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children with acute infection.

You may not qualify if:

  • Hypersensitivity to antibiotics, chronic illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka Medical Center

Beersheba, 84101, Israel

Location

MeSH Terms

Interventions

Inulinfructooligosaccharide

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Zvi Weizman, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2008

First Posted

January 21, 2009

Study Start

December 1, 2008

Primary Completion

December 1, 2009

Study Completion

July 1, 2010

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

IL(1)